EVOXIL 500 MG FILM-COATED TABLETS

PDF Transcript

Package leaflet: Information for user

Evoxil 250 mg film – coated tablets
Evoxil 500 mg film – coated tablets
Levofloxacin
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Evoxil is and what it is used for
2. What you need to know before you take Evoxil
3. How to take Evoxil
4. Possible side effects
5. How to store Evoxil
6. Contents of the pack and other information
1. WHAT EVOXIL TABLETS ARE AND WHAT THEY ARE USED FOR
What this medicine is
The name of your medicine is Evoxil. Evoxil contains a medicine called
levofloxacin. This belongs to a group of medicines called antibiotics.
Levofloxacin is a ‘quinolone’ antibiotic. It works by killing the bacteria that
cause infections in your body.
Evoxil can be used to treat infections of the:
- Sinuses
- Lungs, in people with long-term breathing problems or pneumonia
- Urinary tract, including your kidneys or bladder
- Prostate gland, where you have a long lasting infection
- Skin and underneath the skin, including muscles. This is sometimes called
‘soft tissue’.
In some special situations Evoxil may be used to lessen the chances of
getting a pulmonary disease named anthrax or worsening of the disease after
you are exposed to the bacteria causing anthrax.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EVOXIL
Do not take this medicine and tell your doctor if
• you are allergic to levofloxacin, any other quinolone antibiotic such as
moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of this
medicine (listed in section 6). Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your lips, face, throat or
tongue
• you have, ever had epilepsy
• you have ever had a problem with your tendons such as tendonitis that was
related to treatment with a ‘quinolone antibiotic’. A tendon is the cord that
joins your muscle to your skeleton
• you are a child or growing teenager
• you are pregnant, might become pregnant or think you may be pregnant
• you are breast-feeding.
Tell your doctor if you have had any problems with taking medicines in the
past.
Do not take this medicine if any of the above applies to you. If you are not
sure, talk to your doctor or pharmacist before taking Evoxil.
Warnings and precautions
Talk to your doctor or pharmacist before taking your medicine if:
• you are 60 years of age or older
• you are using corticosteroids, sometimes called steroids (see section
“Other medicines and Evoxil”)
• you have had damage to you brain due to a stroke or other brain injury
• you have kidney problems
• you have ever had a fit (seizure)
• you have something known as ‘glucose-6 phosphate dehydrogenase
deficiency’. You are more likely to have serious problems with your blood
when taking this medicine
• you have mental health problems
• you have ever had heart problems: caution should be taken when using this
kind of medicine, if you were born with or have family history of prolonged
QT interval (seen on ECG, electrical recording of the heart), have salt
imbalance in the blood (especially low level of potassium or magnesium in
the blood), have a very slow heart rhythm (called ‘bradycardia’), have a
weak heat (heart failure), have a history of heart attack (myocardial
infarction), you are female or elderly or you are taking other medicines that
result in abnormal ECG changes (see section ‘Taking other medicines’)
• you are diabetic
• you have ever had liver problems
• you have myasthenia gravis.
If you are not sure if any of the above applies to you, talk to your doctor or
pharmacist before taking Evoxil.
Other medicines and Evoxil
Tell your doctor or pharmacist if you are taking or have recently taken or
might take any other medicines. This is because Evoxil can affect the way
some other medicines work. Also some medicines can affect the way Evoxil
work.
In particular tell your doctor if you are taking any of the following
medicines. This is because it can increase the chance of you getting
side effects, when taken with Evoxil
• warfarin. Used to thin blood. You may be more likely to have a bleed. Your
doctor may need to take regular blood tests to check how well your blood
can clot
• medicines known to affect the way your heart beats. This includes
medicines used for abnormal heart rhythm (antiarrhythmics such as
quinidine, hydroquinidine, disopyramide, solatol, dofetilide, ibutilide and
amiodarone), for depression (trcyclic antidepressants such as amitriptyline
and imipramine), for psychiatric disorders (antipsychotics), and for bacterial
infections (‘macrolide’ antibiotics such as erythromycin, azithromycin and
clarithromycin)
• theophylline - used for breathing problems. You are more likely to have a fit
(seizure) if taken with Evoxil
• probenecid – used for gout and cimetidine - used for ulcers and heartburn.
Special care should be taken when taking either of these medicines with

Evoxil. If you have kidney problems, your doctor may want to give you a
lower dose
• ciclosporin used after organ transplants. You may be more likely to get the
side effects of ciclosporin.
• corticosteroids, sometimes called steroids – used for inflammation. You
may be more likely to have inflammation and/or rupture of your tendons.
• non-steroidal anti-inflammatory drugs (NSAIDS) – used for pain and
inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and
indomethacin. You are more likely to have a fit (seizure) if taken with Evoxil
tablets.
Do not take Evoxil tablets at the same time as the following medicines.
This is because it can affect the way Evoxil tablets work:
• Iron tablets (for anaemia), zinc supplements, magnesium or aluminiumcontaining antacids (for acid or heartburn), didanosine, or sucralfate (for
stomach ulcers). See section 3 “If you are already taking iron tablets, zinc
supplements, antacids, didanosine or sucralfate” below.
Urine tests for opiates
Urine tests may show ‘false-positive’ results for strong painkillers called
‘opiates’ in people taking Evoxil. If your doctor has prescribed a urine test, tell
your doctor you are taking Evoxil.
Tuberculosis tests
This medicine may cause ‘false-negative’ results for some tests used in
laboratory to search for the bacteria causing tuberculosis.
Pregnancy and breast-feeding
Do not take Evoxil tablets if:
• you are pregnant, might become pregnant or think you may be pregnant
• you are breast feeding a baby Or planning to breast-feed.
Driving and using machines
You may get side – effects after taking this medicine, including feeling dizzy,
sleepy, a spinning feeling (vertigo) or changes to your eyesight. Some of
these side effects can affect you being able to concentrate and your reaction
speed. If this happens, do not drive or carry out any work that requires a high
level of attention.
Evoxil tablets contains sunset yellow (E110)
This medicinal product contains the colouring agent sunset yellow (E110),
which may cause allergic reactions.
3. HOW TO TAKE EVOXIL TABLETS
Always take this medicine exactly as your doctor has told you.
Check with your doctor or your pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets whole with a drink of water
• The tablets may be taken during meals or at any time between meals
Protect your skin from sunlight
Keep out of direct sunlight while taking this medicine and for 2 days after you
stop taking it. This is because your skin will become much more sensitive to
the sun and may burn, tingle or severely blister if you do not take the following
precautions:
• make sure you use high factor sun creams
• always wear a hat and clothes which cover your arms and legs
• avoid sun beds.
If you are already taking iron tablets, zinc supplements, antacids,
didanosine or sulcralfate
• Do not take these medicines at the same time as Evoxil film-coated tablets.
Take your dose of these medicines at least 2 hours before or after Evoxil
film-coated tablets.
How much to take
• Your doctor will decide on how many Evoxil film-coated tablets you should
take.
• The dose will depend on the type of infection you have and where the
infection is in your body.
• The length of your treatment will depend on how serious your infection is
• If you feel the effect of your medicine is too weak or strong, do not change
the dose yourself, but ask your doctor.
Adults and the elderly.
Sinuses infection
• Two tablets of Evoxil 250 mg, once each day.
• Or, one tablet of Evoxil 500 mg, once each day.
Lung infection, in people with long term breathing problems.
• Two tablets of Evoxil 250 mg, once each day
• Or, one tablet of Evoxil 500 mg, once each day
Pneumonia
• Two tablets of Evoxil 250 mg, once or twice each day
• Or, one tablet of Evoxil 500 mg, once or twice each day.
Infection of urinary tract, including your kidneys or bladder.
• One or two tablet of Evoxil 250 mg, each day
• Or, ½ or one tablet of Evoxil 500 mg, each day
Prostate gland infection
• Two tablets of Evoxil 250 mg, once each day.
• Or, one tablet of Evoxil 500 mg, once each day.
Infection of the skin and underneath the skin, including muscles
• Two tablets of Evoxil 250 mg, once or twice each day
• Or, one tablet Evoxil 500 mg, once or twice each day
Adults and the elderly with kidney problems
Your doctor may need to give you a lower dose
Children and adolescents
This medicine must not be given to children or teenagers.
If you take more Evoxil tablets than you should

If you accidentally take more tablets than you should, tell a doctor or get other
medical advice straight away. Take the medicine pack with you. This is so the
doctor knows what you have taken. The following effects may happen:
convulsive fits (seizures), feeling confused, dizzy, less conscious, having
tremor and heart problems – leading to uneven heart beats as well as feeling
sick (nausea) or having stomach burning.
If you forget to take Evoxil tablets
If you forgot to take a dose, take it as soon as you remember, unless it is
nearly time for your next dose. Do not double up the next dose to make up for
the missed dose.
If you stop taking Evoxil tablets
Do not stop taking Evoxil just because you feel better. It is important that you
complete the course of tablets that your doctor has prescribed for you. If you
stop taking, the infection may return, your condition may get worse or the
bacteria may become resistant to the medicine.
If you have any further questions on the use of this medicine, ask your doctor
or your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects although not
everybody gets them. These effects are normally mild or moderate and often
disappear after a short time.
Stop taking Evoxil and see a doctor or go to a hospital straight away if
you notice the following side effects:
Very rare (may affect up to 1 in 1,000 people)
• You have an allergic reaction. The signs may include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
Stop taking Evoxil and see a doctor straight away if you notice any of
the following serious side effects – you may need urgent medical
treatment:
Rare (may affect up to 1 in 1,000 people)
• Watery diarrhoea which may have blood in it, possibly with stomach cramps
and a high temperature. These could be signs of a severe bowel problem
• Pain and inflammation in your tendons or ligaments, which could lead to
rupture. The Achilles tendon is affected most often
• Fits (convulsions)
Very rare (may affect up to 1 in 10,000 people)
• Burning, tingling, pain or numbness. These may be signs of something
called ‘neuropathy’
Other:
• Severe skin rashes which may include blistering or peeling of the skin
around your lips, eyes, mouth, nose and genitals
• Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured
urine, itching, or tender stomach (abdomen). These may be signs of liver
problems which may include a fatal failure of the liver
If your eyesight becomes impaired or if you have any other eye disturbances
whilst taking Evoxil, consult an eye specialist immediately.
Tell your doctor if any of the following side effects gets serious or lasts
longer than a few days:
Common (may affect up to 1 in 10 people)
• Sleeping problems
• Headache, feeling dizzy
• Feeling sick (nausea, vomiting) and diarrhoea
• Increase in the level of some liver enzymes in your blood
Uncommon (may affect up to 1 in 100 people)
• Changes in the number of other bacteria or fungi, infection by fungi named
Candida, which may need to be treated
• Changes in the number of white blood cells shown up in the results of some
blood tests (leukopenia, eosinophilia)
• Feeling stressed (anxiety), feeling confused, feeling nervous, feeling
sleepy, trembling, a spinning feeling (vertigo)
• Shortness of breath (dyspnoea)
• Changes in the way things taste, loss of appetite, stomach upset or
indigestion (dyspepsia, pain in the stomach area, feeling bloated
(flatulence) or constipation
• Itching and skin rash, severe itching or hives (urticaria), sweating too much
(hyperhidrosis)
• Joint pain or muscle pain
• Blood tests may show unusual results due to liver (bilirubin increased) or
kidney (creatinine increased) problems
• General weakness
Rare (may affect up to 1 in 1,000 people)
• Bruising and bleeding easily due to lowering in the number of blood
platelets (thrombocytopenia)
• Low number of white blood cells (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Lowering of your blood sugar levels (hypoglycaemia). This is important for
people that have diabetes
• Seeing or hearing things that are not there (hallucinations, paranoia),
change in your opinion and thoughts (psychotic reactions) with a risk of
having suicidal thoughts or actions
• Feeling depressed, mental problems, feeling restless (agitation), abnormal
dreams or nightmares
• Tingly feeling in your hands and feet (paraesthesia)
• Problems with your hearing (tinnitus) or eyesight (blurred vision)
• Unusual fast beating of your heart (tachycardia) or low blood pressure
(hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (a
rare disease of the nervous system)
• Changes in the way your kidney works and occasional kidney failure which
may be due to an allergic kidney reaction called interstitial nephritis
• Fever
Other side effects include:

• Lowering in blood cells (anaemia): this can make the skin pale or yellow
due to damage of the red blood cells; lowering in the number of all types of
blood cells (pancytopenia)
• Fever, sore throat and a general feeling of being unwell that does not go
away. This may be due to a lowering in the number of white blood cells
(agranulocytosis)
• Loss of circulation (anaphylactic like shock)
• Increase of your blood sugar levels (hyperglycaemia) or lowering of your
blood sugar levels leading to coma (hypoglycaemic coma). This is
important for people that have diabetes
• Changes in the way things smell, loss of smell or taste (parosmia, anosmia,
ageusia)
• Problems moving and walking (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision
• Impairment or loss of hearing
• Abnormal fast heart rhythm, life-threatening irregular heart rhythm including
cardiac arrest, alteration of the heart rhythm (called ‘prolongation of QT
interval’, seen on ECG, electrical activity of the heart)
• Difficulty breathing or wheezing (bronchospasm)
• Allergic lung reactions
• Pancreatitis
• Inflammation of the liver (hepatitis)
• Increased sensitivity of your skin to sun and ultraviolet light
(photosensitivity)
• Inflammation of the vessels that carry blood around your body due to an
allergic reaction (vasculitus)
• Inflammation of the tissue inside the mouth (stomatitis)
• Muscle rupture and muscle destruction (rhabdomyolosis)
• Joint redness and swelling (arthritis)
• Pain, including pain in the back, chest and extremities
• Attacks of porphyria in people who already have porphyria (a very rare
metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial
hypertension)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. Also you can help to
make sure that medicines remain as safe as possible by reporting any
unwanted side effects via the internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m.
to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local
pharmacy. By reporting side effects you can help provide more information on
the safety of medicines.
5. HOW TO STORE EVOXIL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is shown on the
packaging. The expiry date refers to the last day of the month.
Keep the blister in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater of household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Evoxil contains
Evoxil tablets are available in two strengths: 250 mg and 500 mg. The active
substance is levofloxacin.
Each Evoxil 250 mg tablet contains levofloxacin hemihydrates equivalent to
250 mg of levofloxacin
Each Evoxil 500 mg tablet contains levofloxacin hemihydrates equivalent to
500 mg of levofloxacin
The other ingredients are:
Tablet core: Microcrystalline cellulose, hydroxypropylcellulose, crospovidone,
magnesium stearate.
Film coating: Hypromellose, FD&C blue #2/Indigo carmine aluminium lake
(E132), FD&C yellow #6/Sunset Yellow aluminium lake (E110), iron oxide red
(E172), macrogol 4000, titanium dioxide (E171). Additionally the 500 mg
tablets contain iron oxide yellow.
What Evoxil looks like and contents of the pack
Evoxil 250 mg film-coated tablets are pink, oblong, biconvex tablets with a
scoreline. The tablet can be divided into equal halves.
Evoxil 500 mg film-coated tablets are orange, oblong, biconvex, tablets with a
scoreline. The tablet can be divided into equal halves.
Evoxil 250 mg film-coated tablets are packed in blister strips, and are
available in pack sizes of 1, 5, 7 and 10 tablets.
Evoxil 500 mg film-coated tablets are packed in blister strips, and are
available in pack sizes of 1, 5, 7 and 10 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Beacon Pharmaceuticals Ltd., 85 High Street, Tunbridge Wells, Kent TN1
1YG, U.K.
Manufacturer
Pharmathen S.A., Dervenakion 6, 15351 Pallini, Attiki, Greece
tel.: +30 210 666 4300 fax: +30 210 666 6749 e-mail: info@pharmathen.com
This leaflet was last approved in…July 2013

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Latest Drug Information Updates

ErleadaErleada (apalutamide) is an oral androgen receptor inhibitor for the treatment of men with non-metastatic...